The Effect of Lipitor on Aortic Stenosis
Stopped early · Phase 4
Conditions studied: Aortic Valve Stenosis
In brief
The purpose of this study is to find out if an approved medicine that is used to lower cholesterol called Lipitor can slow or stop progressive narrowing of the aortic heart valve in patients with a condition called aortic stenosis. Patients who have aortic stenosis who volunteer for this study will take Lipitor for 2 years and will undergo a brief exam by a physician, labwork to measure cholesterol, and a routine heart ultrasound (sound picture of the heart) at the start of the study and every 6 months, stopping at 2 years.
Key facts
- Study ID
- NCT00590135
- Run by
- The Cleveland Clinic
- People needed
- 59
- Starts
- 2000-08-01
- Expected to finish
- 2010-04-26
- Last updated by the study team
- 2017-07-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Mild to moderate calcific AS of a tricuspid or bicuspid aortic valve
- Echocardiographic derived mean pressure gradient >10 mmHg and an aortic valve area of 0.9 to 1.7 cm2 by continuity equation.
- Laboratory evidence of LDL-c>70 mg/dl within 12 months prior to recruitment.
You may not qualify if…
- Left ventricular ejection fraction <50%
- Valvular area of 0.9 cm2 and a mean gradient >30 mmHg
- Rheumatic heart disease
- >Moderate (2+) aortic insufficiency
- Prior statin therapy to include: >10 mg of atorvastatin (Lipitor) or >20 mg of other HMG-CoA Reductase Inhibitors (statins)
- End-stage renal disease (ESRD)
- History of thoracic radiation
- Unable or unwilling to sign informed consent
- Unable to unwilling to return for follow-up
- Other clinically important renal, pulmonary, hepatic, neurological, endocrine, or hematological disorders, vasculitis, or any other situation or medical condition that, in the investigator's opinion, would make survival for the duration of the study unlikely, or would otherwise interfere with optimal participation in the study or produce a significant risk to the patient
- Severe pulmonary hypertension (>55 mmHg)
Where it is running
- The Cleveland Clinic Foundation — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.